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Myths and facts on proposed self-care product regulation

Health Canada has consulted Canadians to seek their views on a new approach to the regulation of self-care products, including natural health products, cosmetics and over-the-counter drugs. As the discussion progresses, a need to clarify some aspects of the proposal has emerged.

Review the facts of Health Canada’s position on the regulation of self-care products.

Product availability

Fact: Natural health products will continue to be readily available. Low-risk products, including many natural health products, will actually get to store shelves faster without compromising safety.

Differences from prescription drugs

Myth: Self-care products will be treated like prescription drugs.

Fact: The rules for self-care products will not be the same as those for prescription drugs.

Self-care products would have the appropriate level of oversight to ensure consumer safety. This oversight would be different from that for prescription drugs since self-care products are generally lower risk.

Ease of bringing products to market

Myth: Health Canada is planning to add more rules and red tape for companies.

Fact: Companies will face less red tape to bring many self-care products to market. The rules will be applied based on the type of risk associated with the product, such as:

higher risk products could receive more review by Health Canada

lower risk self-care products could receive less review and get to market faster

Claims

Myth: Health claims will be banned on self-care products.

Fact: Self-care products will be allowed to make claims if they’re supported by evidence as long as:

all claims are truthful and accurate

scientific evidence supports certain types of claims

claims on packages help consumers make informed choices

Public knowledge

Myth: Canadians are well-informed about the self-care products they use.

Fact: Polling shows that Canadians don’t feel informed when choosing and using self-care products. Public opinion research conducted in April 2016 showed that fewer than 2 in 5 Canadians feel knowledgeable about the effectiveness of self-care products.

Canadians feel like they have little knowledge of the safety and effectiveness of these products, and feel generally uninformed when making a purchase. The self-care proposal will support informed choice.

Product risks

Myth: Natural health productsare safe and don’t need many rules.

Fact: Most natural health products are low risk, but they are not without risk.

There is a wide range of natural health products, some of which can interact with other medications and/or cause serious adverse reactions. Health Canada will continue to have safety checks in place.

Scientific evidence

Myth: There is no scientific evidence to support any natural health products.

Fact: Many natural health products are supported by scientific evidence, while others rely on a history of traditional use or non-scientific information.

Self-care proposal

Myth: Health Canada’s new self-care proposal came out of the blue.

Fact: Health Canada has been looking to modernize the rules for self-care products for some time.Health Canada has been working to modernize its approach to health products, including launching the regulatory roadmap in 2012 and conducting a consultation on consumer health products in 2014. Through the current consultation, the Department wants to hear from Canadians to inform the way forward.

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